BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX15

    MDR report key: 8037121 · Received November 5, 2018

    Report

    Report Number
    9681834-2018-00196
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 5, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR THIS REASON, EVALUATION CODE 11 HAS BEEN REFERENCED IN THE CONCLUSIONS SECTION OF H6. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO FINDINGS. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO UPDATE SECTION AND PROVIDE THE COMPLETED INVESTIGATION RESULTS. IT WAS INITIALLY REPORTED THAT THE DEVICE WAS AVAILABLE FOR EVALUATION, HOWEVER, THE ACTUAL DEVICE IS NO LONGER AVAILABLE FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND A RETENTION SAMPLE OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. VISUAL INSPECTION OF THE RETENTION SAMPLE REVEALED NO DEFECTS. THE RETENTION SAMPLE WAS BUILT INTO A CIRCUIT WITH TUBES AND TESTED FOR ITS O2 TRANSFER AND CO2 REMOVAL PERFORMANCE IN ACCORDANCE WITH THE FACTORY'S SHIPPING INSPECTION PROTOCOL. BOVINE BLOOD WAS CIRCULATED IN THE OXYGENATOR MODULE. NO ANOMALIES WERE REVEALED IN THE GAS TRANSFER PERFORMANCE OF THE ACTUAL SAMPLE, WITH THE OBTAINED VALUES MEETING MANUFACTURER SPECIFICATIONS. THE INVESTIGATION RESULTS VERIFIED THAT THE RETENTION SAMPLE OF THE INVOLVED PRODUCT CODE/LOT# WAS THE NORMAL PRODUCT WITH NO ISSUE IN THE GAS TRANSFER PERFORMANCE. AS A CAUSE OF THIS COMPLAINT, BASED ON THE PUMP RECORD REVIEW, THE FACTORS BELOW CAN BE INFERRED. THE GAS FLOW RATE MAY HAVE BEEN INADEQUATE FOR THE BLOOD FLOW RATE. DURING THE PROCEDURE, THE BLOOD FLOW RATE WAS INCREASED TO APPROXIMATELY 5L/MIN, WHICH IS THE MAXIMUM BLOOD FLOW RATE SPECIFIED FOR FX15. FROM THIS, THE PERFORMANCE OF THE ACTUAL SAMPLE (FX15 SIZE) MAY HAVE NOT BEEN SUFFICIENT FOR THE INVOLVED PATIENT. HOWEVER, WITH NO RETURN OF THE ACTUAL SAMPLE, EXACT CAUSE CANNOT BE DEFINITIVELY DETERMINED. THE IFU STATES: START GAS SUPPLY WITH V/Q=1 AND FIO2=100%, THEN MAKE ADJUSTMENTS BASED ON BLOOD GAS MEASUREMENTS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PATIENT WAS HAVING A MITRAL VALVE REPLACEMENT THAT INVOLVED A CAPIOX DEVICE. DURING TREATMENT BY THE HEART LUNG MACHINE THERE WAS POOR OXYGENATION AT A 3 LITER GAS FLOW, 100% FIO2, PCO2 39.4 AND PO2 79.3. AFTER 17 MINUTES THE HEART-LUNG MACHINE HAS BEEN REPLACED. THE OXYGENATOR WAS REPLACED WITH A MAQUET QUADROX. AFTER THE INCIDENT, THE PATIENT WAS EVENTUALLY TREATED AS INTENDED. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO FOLLOW-UP TREATMENT "WAS" NEEDED.

    Description of Event or Problem · 0

    THE PUMP RECORD OF THE INVOLVED PROCEDURE WAS REVIEWED AS FOLLOWS: FOR THE TIME PERIOD FROM THE INITIATION OF THE CIRCULATION TILL 12:53, WHICH WAS 2 MINUTES AFTER THE INITIATION OF THE CIRCULATION, WHEN THE BLOOD FLOW RATE CAME TO BE STABLE, THE CIRCULATION CONDITIONS WERE AS FOLLOWS. BLOOD FLOW RATE:4.05L/MIN., GAS FLOW RATE:3.0L/MIN AND FIO2:75%. AT 12:59, PCO2 WAS 36.2MMHD AND PO2 WAS 61.1MMHG. THE CIRCULATION CONDITIONS WERE AS FOLLOWS. BLOOD FLOW RATE:3.87L/MIN., GAS FLOW RATE:3.0L/MIN AND FIO2:75%. AT 13:01 AFTER FIO2 WAS INCREASED TO 100% FROM 75%, PCO2 WAS 38.2MMHG AND PO2 WAS 110.0MMHG. PO2 WAS NOTED TO HAVE INCREASED. THE GAS FLOW RATE AT THAT MOMENT WAS 3.0L/MIN. AT 13:06, PCO2 WAS 39.4MMHD AND PO2 WAS 79.3MMHG. THE BLOOD FLOW RATE WAS NOTED TO HAVE BEEN INCREASED TO APPROX. 5L/MIN., WITH THE GAS FLOW RATE:3.0L/MIN AND FIO2:100%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877493 CAPIOX FX15 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 170810

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R